Impaired contractile function after a heart attack of the heart is a major cause of "heart failure" limiting quality of life and prognosis, which cannot be prevented even with optimal standard therapy, including immediate balloon/stent dilation of the infarct vessel. The aim of the REPAIR-AMI trial is to investigate whether infusion of progenitor cells into the infarct vessel (after successful reperfusion therapy) may improve left ventricular contractile function compared to placebo therapy. After bone marrow aspiration progenitor cells are enriched via a centrifugation method.
* The study is a double-blind, placebo-controlled, randomized, multicenter trial. * Patients after an acute myocardial infarction, undergoing successful reperfusion therapy are included. * All patients undergo bone marrow aspiration 3 to 6 days after the infarction. * After cell processing, enriched bone marrow-derived progenitor cells or placebo medium is infused direct into the infarct related artery during stop-flow. In addition, a left ventricular angiography is performed. * After 4 months left ventricular angiography is repeated. The primary endpoint is the difference in change of left ventricular ejection fraction between the two groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
204
Zentralklinik Bad Berka
Bad Berka, Germany
Kerckhoff Klinik
Bad Nauheim, Germany
Herz- und Diabeteszentrum NRW
Change in global left ventricular function in quantitative LV angiography after 4 months.
absolute delta LVEF (%)
Time frame: baseline to 4 months
Primary endpoint in patients without restenosis.
absolute delta LVEF (%)
Time frame: baseline to 4 months
Improvement of regional wall motion in infarct area
Time frame: baseline to 4 months
Reduction of LV end-systolic volume
Time frame: baseline to 4 months
Major adverse cardiac events (MACE)
Time frame: at 4, 12 and 60 months
Rehospitalization due to heart failure.
Time frame: 4, 12, 60 months
NYHA status after 12 months
Time frame: 12 months
Amendment for extended follow up after 2 and 5 years:
Time frame: 24 and 60 months
outcomes in major adverse cardiac events (MACE)
Time frame: 4, 12, 60 months
Rehospitalization due to heart failure
Time frame: 4, 12, 60 months
NYHA status
Time frame: 4, 12, 60 months
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Bad Oeynhausen, Germany
BG Kliniken Bergmannsheil
Bochum, Germany
Klinikum Lippe
Detmold, Germany
Rotes-Kreuz Krankenhaus - Kardiologisches Centrum
Frankfurt, Germany
J. W. Goethe University Hospitals
Frankfurt, Germany
Universitätsklinkum Giessen
Giessen, Germany
Parxis Schofer, Mathey und Partner
Hamburg, Germany
Universitätsklikum Homburg
Homburg/Saar, Germany
...and 7 more locations
patients in MRI subgroup: improvement in left ventricular function
Time frame: 4, 12, 60 months